Related Issues and Solutions to Medical Equipment Knowledge

  Author:MeCan Medical–ultrasound machine manufacturers

As the policy has more and more support for domestic medical device manufacturers, many companies want to engage in the medical device industry, what standards do they need to sell to sell medical devices? What should I do? What are the provisions of the update? What are the solutions related to these medical equipment knowledge? We want to find out in detail for these questions.

1. What are the qualifications to sell medical devices?

One category only requires business licenses and the business scope includes medical device sales, second category to handle medical device filing vouchers, and three types of medical device business licenses.

2. Which companies need to apply for medical device permits?

1. Pharmacy

2. Enterprises operating medical equipment

3. Glasses shop (selling contact lenses)

What qualifications do hospitals need to apply?

Medical institution.

Fourth, how many years are the medical device permit?

5 years.

5. What is medical device business behavior?

Medical device operation refers to the behavior of providing medical device products in the form of purchase and sales, including procurement, acceptance, storage, sales, transportation, and after -sales service.

6. How to replace the expiration of medical device business licenses?

If the expiry of the "Medical Devices Business License" must be continued, medical device operating enterprises shall submit an application for the "Medical Device Business License" to the original certificate department 6 months before the expiry of the validity period.

7. What should I do if the "Medical Device Business License" is lost?

If the "Medical Device Business License" is lost, the medical device business enterprise shall immediately board the loss statement on the media designated by the original certificate department. Since the date of launching the statement, it will be applied for reissue from the original certificate department.

8. What personnel do I need to apply for a medical device license?

The person in charge of the corporate, the person in charge of the enterprise, the person in charge of the quality institution, the person in charge of the quality institution, and the acceptor.

Nine, what are the requirements for handling medical device license venues?

Ordinary two or three categories require 45 square meters, including 100 square meters of in vitro diagnostic reagents, and 130 square meters of sterile products. In addition, in vitro diagnostic reagents require a cold chain, but cold storage can be achieved through third -party logistics or self -built cold storage.

10. What are medical device wholesale and retail?

1. The wholesale of medical device refers to the medical device business operation of medical devices to a qualified business enterprise or using the unit.

2. Medical device retail refers to the operational behavior of selling medical devices directly to consumers.

11. What are the changes in the "Medical Device Business License"?

The change of medical device business permits is divided into changes and changes of the license matters and changes in registration. The change of permission includes changes in operating venues, business methods, business scope, and warehouse address. The change of registration is the change of other matters other than the above items. If the license is changed, the application for changes in the "Medical Device Business License" shall be submitted to the original certificate department and submitted relevant information.

12. How to store medical devices in partitional classification management?

Strictly managed in accordance with the three -color classification of the Five Districts, qualified areas, shipping areas (green), to the inspection area, return area (yellow), and unqualified area (red).

13. What are the qualifications for medical device network sales?

Second -category medical device sales filing or medical device sales license and medical device network sales information table; if it is self -built website sales medical device, you need to obtain the "Internet Drug Information Service Qualification Certificate" in accordance with the law.

14. What should the medical devices published online by the online sales of medical device networks should include?

It should include names, models, specifications, structures and compositions, scope of application, medical device registration certificate number or filing voucher number, registered person or recorder information, production license or filing voucher number, product technical requirements, contraindications, etc. It should be consistent with the relevant content of registration or filing.

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  Author:MeCan Medical–ultrasound machine manufacturersWhat is an electrolyte analyzer? Many people have not been exposed to this testing equipment, or when they usually do not pay much attention, they may be unfamiliar with this commonly used inspection device. In fact, there are many applications of electrolyte analysis. With the continuous development of domestic medical technology, the demand for diagnosis and treatment and testing has increased. Therefore, the accuracy and detection speed of the detection equipment are more serious. Then, let's take a detailed understanding of this electrolyte together Analysis instrument equipment.The electrolyte analyzer is an instrument that detects potassium ions, sodium ions, chloride ions, ion calcium and lithium ions from the samples. For many samples, such as whole blood, serum, plasma, urine, osmotic fluid and hydration When solution, etc., when the electrolyte concentration in the blood and dialysis solution is significantly different, the electrolyte will be diffused from the high concentration to the low, such as the spread from the blood to the dialysis solution, or the opposite.After a simple understanding of the basic definition of electrolyte analyzers, we will understand how it is tested? The electrolyte analyzer uses an ions to select the electrode measurement method to achieve detection. There are six electrodes on the instrument, namely sodium, potassium, chlorine, ionic calcium, lithium and reference electrodes. Each electrode has an ion selection film. Reaction to the corresponding ions in the measured sample, the membrane is a ion exchanger, which reacts with the ionic charge to change the membrane potential, which can detect the potential of the liquid, sample, and the membrane.The application of electrolyte analyzers is also widely used, mainly clinically, and electrolyte analyzers are indispensable, mainly used to maintain human blood, because the balance of osmotic pressure in the body fluid is under surgery, burns, diarrhea, acute myocardial infarction, acute myocardial infarction Among patients who need a large amount of balanced fluid, the detection of ions is important, because the precision of the instrument is also highly accurate, and the results, reliability, speed, and operation of any sample are very simple. Ionic detection is general equipment.As a manufacturer of electrolyte analyzer, Progen Medical Equipment is currently available for electrolytic analyzers, and a variety of different models to choose from. If you have a plan to purchase electrolyte analyzer recently, you can call to consult in detail: 400-6656 -888, pre -sales personnel will recommend appropriate products according to your needs.
Use Steps and Precautions for the Use of Biochemical Analyzers
Use Steps and Precautions for the Use of Biochemical Analyzers
  Author:MeCan Medical–ultrasound machine manufacturersThe biochemical analyzer is also called the biochemical instrument. It is a comprehensive analysis of various biochemical indicators for the measurement of blood and other body fluids, and then combined with other clinical data to make a comprehensive analysis of organ functions to help diagnose diseases. How to use the biochemical analyzer?1. How to use the biochemical analyzer1. Start work inspection. Whether the probe and stirring rod have water droplets, dirty dirt, whether to bend or block. Whether the cleaning agent is sufficient can be used for one week, but it needs to be checked every day. Whether the liquid suction mechanism leaks liquid. Whether the waste liquid box is full.2. Connect the power. Prepare the ion exchanges water installation, and use distilled water for later use. Place the host power switch at the (ON) position. Biochemical analyzers enter the preheating state.3. Prepare reagents. Enter the reagent information program, stick a barcode label reagent, and you can read the reagent information of each item from the barcode. The remaining dosage can be recorded in the level of information without barcodes. According to the specific specimen volume and additional reagent reagent of the project on the day of the laboratory, the lid is added to the CESHI agent program.4. General sample registration and entry. Each sample registration, select the sub -menu of conventional operation, enter the start number of the registration sample at the place, and enter the patient's ID, blood collection time, gender, age and other patient information if necessary. Select the required determination of the sample, press Enter to confirm, and automatically convert it to the next two sample numbers. When registering multiple samples in batches, batch registration is performed.5. Prepare samples. The prepared samples, mass controls, and standard solution are stored in the sample disk.6. Start analysis. In the standby state, the biochemical analyzer selects the start button. At the monitoring window of the biochemical analyzer, monitor the analysis of the sample. Enter the (result printing) state after the measurement. The reaction cup and probe used for cleaning, the biochemical analyzer turned into a state of stopping.7. Confirmation of calibration results. Confirm the indoor quality control within 2s and standard curves and calibrations.8. End work. After the measurement results are printed, turn off the power, turn off the power supply of the faucet and the ion exchange water equipment, and do a good job of finishing work.2. Precautions for the use of biochemical analyzers1. The electronic AC regulator to be configured by the biochemical analyzer to prevent the measurement result or damaging the instrument due to the fluctuation of the power supply. In addition, the instrument must have a good ground.2. Biochemical analyzer studio away from the electromagnetic field and X -ray source. There must be no dust and dryness, and the ambient temperature is kept within (15-30) .3. Do not frequently switch the biochemical analyzer in a short time. The continuous work of the instrument generally does not exceed 4h.4. If the biochemical analyzer is not used for a long time, it is necessary to ensure that the power is turned on every half a month, 4h each time, so as to charge the battery in the instrument and drive the moisture in the circuit.5. The printer must change the new printing paper before the paper roll is fast.6. Rinse it with distilled water after turning it every day, which is conducive to the cleaning of pipelines and zero samples.7. When encountering a standard measurement project, the standard should be measured again, so that the accuracy of the result can be judged according to the level of the standard value.8. When the measurement of the specimen is added, it should be arranged according to the reaction color due to the reaction color. Each sample should be used to apply distilled water as a sample, and then make the next sample, which can prevent cross -pollution effects.9. Do your daily maintenance work.The above detailed introduction of the daily use and maintenance methods of biochemical analyzers. According to specifications and correct operations, in addition to detecting the accuracy of the data, it can also avoid affecting the service life of the equipment due to improper operation. As a manufacturer of biochemical analyzers, Pronuni Medical, if you are interested in our products, you can consult: 400-6656-888.
What Are the Methods of Care After Using Non -invasive Ventilator?
What Are the Methods of Care After Using Non -invasive Ventilator?
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What Is Color Doppler Ultrasound? Color Doppler Ultrasound Basic Principle Introduction
What Is Color Doppler Ultrasound? Color Doppler Ultrasound Basic Principle Introduction
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Why Pay Attention to the Problem of Veterinary Drug Residues, Which Areas Can the Veterinary Drug Re
Why Pay Attention to the Problem of Veterinary Drug Residues, Which Areas Can the Veterinary Drug Re
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Brief Analysis of the Importance of Preventive Maintenance Management on Medical Equipment
Brief Analysis of the Importance of Preventive Maintenance Management on Medical Equipment
  Author:MeCan Medical–ultrasound machine manufacturersThe hospital's modernization is inseparable from various advanced medical equipment, and the use of advanced medical equipment helps doctors to better judge the patient's condition. However, for medical equipment, high precision, high -priced, complex maintenance, shorter update cycle, the installation and use environment of equipment also requires relatively high requirements.In some large hospitals, medical equipment, as a fixed assets of the hospital, occupies more than half of the total asset value, and it is undoubtedly of great significance for the management of medical equipment. Preventive maintenance of medical equipment is the basis for managing medical equipment, extending the service life of medical equipment, and improving the accuracy of medical equipment diagnosis of diseases.Therefore, it is of great significance to improve the attention of medical equipment maintenance and establish and improve the management system of medical equipment in the hospital.Preventive maintenance concept: Preventive maintenance means that within a certain cycle, the device can systematically check, detect, maintain, and replace the wear parts, so that the equipment can work normally. Through preventive maintenance, the fault rate of the equipment is reduced, the maintenance time of maintenance is reduced, and the work of various tasks will be carried out smoothly.The necessity of implementation of anti -maintenance: The maintenance of medical equipment after use is essential. The implementation of preventive maintenance is to regularly maintain medical equipment. By maintaining the equipment to familiarize the structure of the device, understand the current equipment. During the maintenance process, the maintenance personnel accurately record the important conditions such as the equipment indicator and the work parameters, and then can make a rapid judgment of the fault position after recording the contrast after the medical equipment fails.Through preventive maintenance, the situation of the easy -to -wear parts of medical equipment, timely purchase parts and replace it, thereby reducing the incidence of medical equipment failure, avoiding normal examination and treatment of patients due to medical equipment failure or medical accidents. Implementation of preventive maintenance will allow medical equipment to run for a long time in a healthy state, and the service life will be extended. If you want to know more, please pay attention to the "Prun Medical Device Network", we will regularly update some new content for everyone to browse and read.
Brief Analysis of the Current Development Status and Trend of Chinese Medical Device
Brief Analysis of the Current Development Status and Trend of Chinese Medical Device
  Author:MeCan Medical–ultrasound machine manufacturersAt present, the epidemic is still spreading globally, and international trade and economic growth have stalled. Although the exports of Chinese medical equipment remain stable as a whole, they need to be alert to relevant risks and challenges. The relevant person in charge of the Medical Institution Department of the Medical Insurance Chamber of Commerce pointed out that in the short term, due to the needs of epidemic prevention and immunity, the global market has increased its dependence on the supply chain of Chinese medical device.In the long run, the epidemic has become a catalyst for reshaping the global industrial structure. With the introduction of policies in various countries, international competition will intensify, and the competition between Chinese medical devices in the global market will be more intense.In terms of market risks, the global economic recovery will lower the ability of the international market to procure ordinary medical supplies. The surge in demand for epidemic prevention materials, coupled with the decline in the efficiency of the port work, has caused serious lag in the circulation of containers, bringing a sharp increase in international logistics costs, especially shipping. The rise in raw materials and labor costs, and the strengthening of the supervision of merchants by cross -border e -commerce platforms will further squeeze the export profits of the enterprise.In addition, due to international travel restrictions, it is difficult for engineers and sales staff to conduct promotion activities in overseas markets and after -sales service for some large -scale equipment exported equipment, and it is not conducive to market sales.Overseas market expansion also needs to focus on the impact of changes in international market regulations. For example, the European Union has implemented new medical device regulations (MDR) and in vitro diagnostic medical device regulations (IVDR), pay more attention to the clinical performance of the product, strengthen the traceability of medical device products, and pay attention to improving the transparency of patients.These will improve the management and restrictions on medical device products entering the European market accordingly, and put forward higher requirements for the industry's employees, which will bring about increased costs to Chinese export companies, extending certification cycle, and increasing compliance risks, etc. challenge.
Let's Briefly Introduce the Application of Enzymes Immune Detector in Pesticides and Food
Let's Briefly Introduce the Application of Enzymes Immune Detector in Pesticides and Food
  Author:MeCan Medical–ultrasound machine manufacturersThe enzyme missionary instrument is commonly known as the enzyme -linked immunohistic detection instrument. It can be simply divided into two categories: semi -automatic and fully automatic, but its working principles are basically the same. The core of its core is a color meter, that is, the color method is used to analyze the content of the antigen or antibody. Clinical examination, biology research, agricultural science, food and environmental science. Let me introduce the application of enzyme -linked immune detector in pesticides and food.1. Fast diagnosis of animal epidemic.The enzyme -linked immune analyzer adopts the enzyme -linked immune adsorption measurement method and the corresponding reagent with a qualitative or quantitative animal disease diagnosis. Such as: pork blue ear virus, swine fever virus, pig pseudo -rabies virus, pig pseudo -rabies virus GE protein, pig ring virus, pork type encephalitis virus, pig mouth hoof disease 3ABC protein, pig mouth hoof disease virus IgG, pork fine virus, chicken chicken, chicken Bird flu, blue tongue disease, white spot syndrome, cattle infectious pleural pneumonia, cattle plague, cotton acne, and sheep acne detection.Second, pesticide residues.Organic phosphorus pesticides are commonly used in agricultural production in my country. Common types include methylmine, dichlorvos, oxygen fruit, phosphorus, and enemies. Most of them are highly toxic pesticides. By reducing the activity of cholthyne enzymes in the body, delayed neurotoxicity is caused, thereby achieving the purpose of eliminating pests. The enzyme -linked immune detector can be used to detect the methamidine content contained in fruits and vegetables.Third, food safetyThe enzyme -linked immune analysis method uses the special nature of the antibody and the corresponding antigen to detect the antibody contained in the food based on this. The immune enzyme method is to use specific enzymes as detection tags and reaction catalysts. The use of this method can be used to effectively avoid using radioactive elements during the detection process, or to conduct orientation and quantitative analysis of the detected objects. , Chemical residue, edible oil testing, water and wine beverage analysis, condiments, edible pigment, etc.At present, more automatic enzyme -linked immune detectors can be used for qualitative detection and quantitative detection. The detection only takes a few hours. It not only reduces the labor intensity of laboratory personnel, but also greatly improves the accuracy and repeatability of the determination. This is conducive to the further commercialization of ELISA technology in detection and analysis.
How Does the Magnetic Pearl Nucleic Acid Extraction Extract Nucleic Acid and Where Is the Advantage?
How Does the Magnetic Pearl Nucleic Acid Extraction Extract Nucleic Acid and Where Is the Advantage?
  Author:MeCan Medical–ultrasound machine manufacturersAs one of the current effective epidemic prevention and control methods, nucleic acid extraction and testing are no stranger to everyone. Prior to this, the method of extracting the traditional nucleic acid was chemical cracking and cylindrical method. However, with the rapid development of gene diagnosis, genetically modified food detection, and personalized medical care, traditional nucleic acid extraction technology can no longer meet the needs of today's biotechnology. As a result, magnetic pearl nucleic acid extraction came into being.No. A commercialized reagent that used the magnetic bead method to extract DNA and successfully applied for patents in the United States appeared in 1998. The magnetic bead method first absorbs the free nucleic acid molecule to the surface of the magnetic particles by cracking the cells, while the protein and polysaccharides are left in the solution. Under the influence of the magnetic field, the magnetic particles are separated from the liquid to discard the liquid to eliminate the liquid Later, the purified nucleic acid molecules were obtained after being eluted.The magnetic bead method uses the principle of combining and dissipating the magnetic acid activity group with a magnetic granular activity group under certain conditions to avoid the loss of nucleic acid during the extraction process as much as possible, and it can also remove the interference substances in the specimen (such as hemoglobin The effects of bilirubin and lipid blood), obtain high -quality nucleic acid templates. With the development of magnetic bead method extraction technology, DNA extraction has really begun to achieve standardization, rapidness and automation.The kits based on the magnetic acid extractor of the Magnetic Pearl Method are also widely used. Nucleic acid extraction kit does not require any organic solvent and no need to repeat centrifugation. At present, it can extract high -quality DNA and RNA from full blood, serum, plasma, saliva, urine, feces, cerebrospinal fluid, tissue and cells, and shorter time. The recovery rate is higher. And it can be automated and uninvited through mechanical equipment.In addition, the principle of magnetic pearl method is safe and non -toxic, and does not use toxic reagents such as benzene and chloroform in traditional methods. Mainstream nucleic acid extraction methods at home and abroad.
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